Gene Therapy, Gen-1, Shows Promise in Treating Advanced Ovarian Cancer

A promising new gene therapy, Gen-1, may improve the prognosis of advanced ovarian cancer, according to findings from the phase 1/2 OVATION 2 study.

The study involved 87 patients with advanced ovarian cancer: 46 who were given Gen-1 and neoadjuvant chemotherapy, and 41 patients were in the control group, who were only given neoadjuvant chemotherapy. Of note, neoadjuvant treatment is given in an effort to shrink a tumor prior to the main treatment method, which is usually surgery.

When patients are injected with Gen-1, their cells secrete IL-12 protein which induces T-lymphocyte and natural killer cells that attack the cancer.

Phase 2 of the OVATION 2 study revealed that the patients in the experimental group had 33% improvement in progression-free survival (time from treatment until disease worsens) compared to the control group. Based on these results, it was recommended that the study continue treating patients with Gen-1. Celsion also reported that over 87% of the projecting 110 patients have been enrolled in the study.

In February 2021, Celsion, the manufacturer of the drug, announced that Gen-1 received FDA fast track designation in advanced ovarian cancer, allowing the company to begin phase I of their study.

This study is particularly important because ovarian cancer is the fifth deadliest disease faced by women in the United States. The majority of the approximately 22,000 new cases of ovarian cancer every year are considered advanced (stages 3 or 4). Stage 3 ovarian cancer has an average five-year survival rate of 41% and stage 4 ovarian cancer has an average five-year survival rate 20%, illustrating the clear need for new treatments to give advanced ovarian cancer patients better prognosis. 

Celsion executive vice president and chief medical officer Dr. Nicholas Borys stated, “findings from our OVATION 2 study show a consistent favorable trend in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment.”

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